Abstract

Background

The combination of 5-HT3- and NK1-receptor-antagonists (RA) and dexamethasone is recommended by international guidelines for patients receiving highly emetogenic (HEC) and anthracycline / cyclophosphamide (AC) containing chemotherapy as well as for patients receiving certain moderately emetogenic chemotherapy (MEC) regimens for the prevention of chemotherapy-induced nausea and vomiting (CINV). NEPA (Akynzeo®) is a fixed combination capsule that combines the new NK1-RA netupitant and the 5-HT3-RA palonosetron. It has been approved for the prevention of acute and delayed CINV in adult cancer patients receiving cisplatin-based HEC or MEC. The objective of the study is to evaluate the quality of life of adult cancer patients undergoing MEC or HEC and receiving NEPA for CINV prophylaxis and to investigate the efficacy and safety of NEPA under real life conditions.

Trial design

This non interventional study is planned to evaluate 2500 patients receiving single day or two day MEC or HEC (10-20 patients / participating center) treated in > 100 German centers (min. 125, max. 250 centers). NEPA is prescribed in accordance with the terms of the marketing authorisation. The primary endpoint is the patientś quality of life as recorded by FLIE questionnaires. Secondary endpoints include complete response (CR, no vomiting, no rescue medication), additional medication, safety data and AEs as documented by online questionnaire and patient diary. 3 consecutive chemotherapy cycles will be documented. For documentation treating physicians use the ODM QuaSi® online documentation system. All specifications in the online documentation system must be verifiable by patient records or medical test records. The trial is in ongoing. At the time of abstract submission, 178 patients treated in 129 centers (69 gynaecologic oncology, 58 medical oncology, 2 urologic oncology) had been included. The majority of patients (118) had breast cancer. Data on quality of life, efficacy and toxicity as available at the cut-off date May 2016 will be presented at the meeting.

Clinical trial identification

DRKS00009316

Legal entity responsible for the study

Riemser Pharma GmbH

Funding

Riemser Pharma GmbH

Disclosure

M. Karthaus: Consultant for Helsinn Healthcare, Riemser Pharma. J. Schilling: Consultant of Riemser Pharma. All other authors have declared no conflicts of interest.